FDA Inspection
Calvin Scott & Company, Inc.Calvin Scott & Company, Inc. – FDA Inspection, Aug 1, 2013
Record Details
This FDA Inspection record concerns Calvin Scott & Company, Inc., with an inspection on August 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Calvin Scott & Company, Inc.
- Inspection Date
- August 1, 2013
- Product Type
- Drugs
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ID · bed8da9f-89d6-45e9-9cf3-117aa06c9699
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844823
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Calvin Scott & Company, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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